Can We Trust Food Health Claims?
The evaluation that leads to approval to market a new drug in the United States is more stringent than that applied to health benefits claimed for a food product or nutritional supplement, something the Institute of Medicine recommends should be changed. An IOM committee released a report last week saying FDA should treat both the same because there are no scientific grounds for treating them differently.
To cut costs and save time, companies often measure effects on biomarkers, which substitute for clinical outcomes -- blood level of harmful cholesterol is used to measure the risk of heart disease, for example, even if the product hasn't been shown to decrease heart disease, according to IOM. Saying FDA does not have a process broadly accepted across the regulatory, food, and medical communities to evaluate biomarkers as appropriate substitutes for clinical outcomes, however, the committee proposed a three-part framework to assess their use for foods and drugs.
The report also said Congress should allow FDA to study drugs and devices after they're approved if that outcome was based on studies that used biomarkers, and FDA should study how well consumers understand foods' and supplements' health claims.
"Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medications, and this committee thinks that should in fact be the case," said John Ball, the committee's chair and executive vice president of the American Society for Clinical Pathology. "Without changes in the way biomarkers are used and assessed, however, health care providers, regulators, and consumers will not be able to reliably collect or judge information to support claims."
The report is available at www.nap.edu.
Posted by Jerry Laws on May 17, 2010